ZYDOL 50 Milligram Capsules Hard
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
07-11-2015
Summary of Product characteristics
(SPC)
21-10-2016
Active ingredient:
TRAMADOL HYDROCHLORIDE
Available from:
Grünenthal Ltd
ATC code:
N02AX02
INN (International Name):
TRAMADOL HYDROCHLORIDE
Dosage:
50 Milligram
Pharmaceutical form:
Capsules Hard
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Other opioids
Authorization status:
Authorised
Authorization date:
2004-12-22
Patient Information leaflet
ie-spc-solution-for-injection-clean
Date: Jul 2015
Details: Type IA in – change to HPRA from IMB
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PACKAGE LEAFLET: INFORMATION FOR THE USER
ZYDOL 50 MG HARD CAPSULES
TRAMADOL HYDROCHLORIDE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you
have any further questions, ask your doctor or pharmacist.
-
This medicine has
been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side
effects talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet (section 4).
IN THIS LEAFLET:
1. What ZYDOL Capsules is and what it is used for
2. What you need to know before you take ZYDOL Capsules
3. How to take ZYDOL Capsules
4. Possible side effects
5. How to store ZYDOL Capsules
6. Contents of the pack and other information
1. WHAT ZYDOL IS AND WHAT IT IS USED FOR
The full name of your medicine
is
‘ZYDOL 50 mg Hard Capsules’
it is
referred to as
‘ZYDOL’ in the rest of this leaflet.
Tramadol - the active substance in ZYDOL - is a painkiller belonging to the class of opioids that acts
on the central nervous system. It relieves pain by acting on specific nerve cells of the spinal cord and
brain.
ZYDOL is used for the treatment of moderate to severe pain.
_ _
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZYDOL
DO NOT TAKE ZYDOL
-
if you are allergic to tramadol or any of the other ingredients of this medicine (listed in section
6);
-
in acute poisoning with alcohol, sleeping pills,
p
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
ZYDOL 50 mg Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule, hard contains 50 mg tramadol hydrochloride.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard
Yellow/yellow, shiny oblong, hard gelatin capsules.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of moderate to severe pain.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The dose should be adjusted to the intensity of the pain and the sensitivity of the individual patient. The lowest
effective dose for analgesia should generally be selected. The total daily dose of 400mg active substance should not be
exceeded, except in special clinical circumstances.
Unless otherwise prescribed, ZYDOL should be administered as follows:
Adults and adolescents aged of 12 years and over
ACUTE PAIN: An initial dose of 100 mg is usually necessary. This can be followed by doses of 50 or 100mg at 4-6 hourly
intervals, and duration of treatment should be matched to clinical need (see section 5.1).
PAIN ASSOCIATED WITH CHRONIC CONDITIONS: An initial dose of 50 mg is advised and then titration according to pain severity.
The need for continued treatment should be assessed at regular intervals as withdrawal symptoms and dependence have been
reported (see section 4.4)
Children
ZYDOL capsules are not suitable for children below the age of 12 years.
Older patients
A dose adjustment is not usually necessary in patients up to 75 years without clinically manifest hepatic or renal
insufficiency. In elderly patients over 75 years elimination may be prolonged. Therefore, if necessary, the dosage
interval is to be extended according to the patient’s requirements.
Patients with renal insufficiency/dialysis and hepatic
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